1.Comparison of efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children: a multicenter, randomized, controlled clinical trial
Xing XIAO ; Shan WANG ; Huan YANG ; Hong SHU ; Yanping GUO ; Jinping CHEN ; Yao LU ; Qinfeng LI ; Yuan LIANG ; Mutong ZHAO ; Xiaoyan LUO ; Limin MIAO ; Rui XU ; Xuemei LI ; Sha LAI ; Jianhong LI ; Zhen LUO ; Lu YU ; Lu XING ; Meitan WANG ; Xiaoli LI ; Haitao XU ; Ping LI ; Hua WANG ; Lin MA
Chinese Journal of Dermatology 2025;58(5):425-430
Objective:To compare the efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged 2 years or older.Methods:A multicenter, randomized, open-label, controlled clinical trial was conducted. A total of 120 pediatric patients aged 2 - 17 years with mild to moderate atopic dermatitis were enrolled from departments of dermatology of 8 hospitals in China between March 2022 and February 2023. The participants were randomly assigned in a 1∶1 ratio to the crisaborole group and the pimecrolimus group, and received the treatment with crisaborole ointment 2% and pimecrolimus cream 1% respectively, twice a day for 4 weeks. Visits were scheduled at baseline/on day 1, as well as on days 8, 15, and 29. The primary efficacy outcome was the percentage of patients achieving the Investigator's Static Global Assessment (ISGA) success (defined as clear [0] or almost clear [1] on the ISGA scale, combined with ≥ 2‐grade improvement from baseline) on day 29. The secondary efficacy outcomes included changes in the Eczema Area and Severity Index (EASI) total scores from baseline to day 29, percentages of patients achieving ISGA improvement (defined as clear [0] or almost clear [1] on the ISGA scale), as well as changes in the Peak Pruritus Numerical Rating Scale (NRS) scores, Dermatology Life Quality Index (DLQI) /Infants' Dermatology Life Quality Index (IDLQI) /Children's Dermatology Life Quality Index (CDLQI) scores, and in the Dermatitis Family Impact (DFI) scores. Drug safety was evaluated according to the incidence of adverse events. Categorical data were compared using the chi-square test. Since measurement data did not follow a normal distribution, the rank sum test was used for comparisons of measurement data between groups.Results:A total of 106 children with mild to moderate atopic dermatitis were included in the per-protocol analysis set, with 52 in the crisaborole group (26 males and 26 females) and 54 in the pimecrolimus group (27 males and 27 females). There were no significant differences in age, disease duration, ISGA and EASI scores at baseline between the two groups (all P > 0.05). On day 29, 22 patients (42.31%) in the crisaborole group and 25 (46.30%) in the pimecrolimus group achieved ISGA success, with no significant difference between the two groups ( χ2 = 0.17, P = 0.68) ; 35 patients (67.31%) in the crisaborole group and 45 (83.33%) in the pimecrolimus group achieved ISGA improvement, also with no significant difference between the two groups ( χ2 = 3.68, P = 0.06) ; additionally, there were no significant differences in the EASI, pruritus NRS, DLQI/IDLQI/CDLQI, or DFI scores between the two groups (all P > 0.05). Adverse reactions to the two topical agents were mainly local reactions such as mild to moderate pain, itching, or worsening of itching, and no obvious systemic adverse reactions occurred. The incidence of drug-related adverse reactions was 46.15% (24 cases) in the crisaborole group and 37.04% (20 cases) in the pimecrolimus group, with no significant difference between the two groups ( χ2 = 0.91, P = 0.34) . Conclusion:The efficacy of crisaborole ointment 2% was comparable to that of pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged ≥ 2 years, and it yielded early and rapid improvement in the quality of life of patients and their families, with good safety and tolerability profiles.
2.Comparison of efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children: a multicenter, randomized, controlled clinical trial
Xing XIAO ; Shan WANG ; Huan YANG ; Hong SHU ; Yanping GUO ; Jinping CHEN ; Yao LU ; Qinfeng LI ; Yuan LIANG ; Mutong ZHAO ; Xiaoyan LUO ; Limin MIAO ; Rui XU ; Xuemei LI ; Sha LAI ; Jianhong LI ; Zhen LUO ; Lu YU ; Lu XING ; Meitan WANG ; Xiaoli LI ; Haitao XU ; Ping LI ; Hua WANG ; Lin MA
Chinese Journal of Dermatology 2025;58(5):425-430
Objective:To compare the efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged 2 years or older.Methods:A multicenter, randomized, open-label, controlled clinical trial was conducted. A total of 120 pediatric patients aged 2 - 17 years with mild to moderate atopic dermatitis were enrolled from departments of dermatology of 8 hospitals in China between March 2022 and February 2023. The participants were randomly assigned in a 1∶1 ratio to the crisaborole group and the pimecrolimus group, and received the treatment with crisaborole ointment 2% and pimecrolimus cream 1% respectively, twice a day for 4 weeks. Visits were scheduled at baseline/on day 1, as well as on days 8, 15, and 29. The primary efficacy outcome was the percentage of patients achieving the Investigator's Static Global Assessment (ISGA) success (defined as clear [0] or almost clear [1] on the ISGA scale, combined with ≥ 2‐grade improvement from baseline) on day 29. The secondary efficacy outcomes included changes in the Eczema Area and Severity Index (EASI) total scores from baseline to day 29, percentages of patients achieving ISGA improvement (defined as clear [0] or almost clear [1] on the ISGA scale), as well as changes in the Peak Pruritus Numerical Rating Scale (NRS) scores, Dermatology Life Quality Index (DLQI) /Infants' Dermatology Life Quality Index (IDLQI) /Children's Dermatology Life Quality Index (CDLQI) scores, and in the Dermatitis Family Impact (DFI) scores. Drug safety was evaluated according to the incidence of adverse events. Categorical data were compared using the chi-square test. Since measurement data did not follow a normal distribution, the rank sum test was used for comparisons of measurement data between groups.Results:A total of 106 children with mild to moderate atopic dermatitis were included in the per-protocol analysis set, with 52 in the crisaborole group (26 males and 26 females) and 54 in the pimecrolimus group (27 males and 27 females). There were no significant differences in age, disease duration, ISGA and EASI scores at baseline between the two groups (all P > 0.05). On day 29, 22 patients (42.31%) in the crisaborole group and 25 (46.30%) in the pimecrolimus group achieved ISGA success, with no significant difference between the two groups ( χ2 = 0.17, P = 0.68) ; 35 patients (67.31%) in the crisaborole group and 45 (83.33%) in the pimecrolimus group achieved ISGA improvement, also with no significant difference between the two groups ( χ2 = 3.68, P = 0.06) ; additionally, there were no significant differences in the EASI, pruritus NRS, DLQI/IDLQI/CDLQI, or DFI scores between the two groups (all P > 0.05). Adverse reactions to the two topical agents were mainly local reactions such as mild to moderate pain, itching, or worsening of itching, and no obvious systemic adverse reactions occurred. The incidence of drug-related adverse reactions was 46.15% (24 cases) in the crisaborole group and 37.04% (20 cases) in the pimecrolimus group, with no significant difference between the two groups ( χ2 = 0.91, P = 0.34) . Conclusion:The efficacy of crisaborole ointment 2% was comparable to that of pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged ≥ 2 years, and it yielded early and rapid improvement in the quality of life of patients and their families, with good safety and tolerability profiles.
3.Application of Enhanced Recovery after Surgery in Interventional Treatment of Tracheal Malignant Tumor.
Hongwu WANG ; Qinghao CHENG ; Lingyu KONG ; Li SHEN
Chinese Journal of Lung Cancer 2019;22(1):1-5
Currently, enhanced recovery after surgery (ERAS) has been widely accepted by surgery and anesthesiology all over the world, and applied in colorectal surgery, gynecology, liver surgery, breast surgery, urology and spinal surgery. But ERAS are rarely used in the field of interventional bronchoscopy. In recent years, more and more researchers have begun to explore the application of ERAS in bronchoscopic interventional therapy. This article discussed that preoperative preparation, anesthesia, intraoperative operation, postoperative observation and other aspects can influence interventional bronchoscopy.
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Anesthesia
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methods
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Bronchoscopy
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methods
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Humans
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Length of Stay
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Outcome Assessment (Health Care)
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Perioperative Care
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methods
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Recovery of Function
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Tracheal Neoplasms
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physiopathology
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surgery
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Tracheotomy
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methods
4. Efficacy and safety of vandetanib on advanced medullary thyroid carcinoma: single center result from a phase Ⅲ study
Shixu WANG ; Xiwei ZHANG ; Xiaoxin WANG ; Changming AN ; Yabing ZHANG ; Wan LIU ; Yanfeng ZHAO ; Xiaohui HE ; Zhengjiang LI ; Lijuan NIU ; Pingzhang TANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2019;54(6):439-444
Objective:
There is no effective therapy for patients with advanced medullary thyroid carcinoma (MTC). Vandetanib,a novel multitargeted receptor tyrosine kinase inhibitor, has previously shown antitumor activity in phase Ⅱ studies of patients with advanced MTC. This study was to evaluate the efficacy and the safety of vandetanib on advanced MTC.
Methods:
This study was an open, international multi-center phase Ⅲ clinical trial and the study number was NCT01298323. The single-center study was a sub-group analysis of the international study, which was conducted on 9 pathologically confirmed advanced MTC patients by Cancer Hospital Chinese Academy of Medical Sciences between March 2012 and October 2017. Vandetanib (300 mg) was orally administered daily till death or withdrawal. The efficacy was evaluated according to RECIST criteria and the adverse events were evaluated according to NCI criteria.
Results:
The objective response rate was 3/9,and the disease control rate was 4/9. The median progression-free survival was 44 months. All patients who had the elevated levels of calcitonin (CTN) and carcino-embryonic antigen (CEA) before treatment began to show the decreases in the level of CTN and CEA after 3 months and later showed again the increases in the levels of both tumor markers with tumor progression. By ROC curve analysis, CTN was of statistically significance(
5.Familial Nonmedullary Thyroid Carcinoma: A Retrospective Analysis of 117 Families.
Ya-Bing ZHANG ; Xiao-Xin WANG ; Xi-Wei ZHANG ; Zheng-Jiang LI ; Jie LIU ; Zhen-Gang XU ; Ping-Zhang TANG
Chinese Medical Journal 2018;131(4):395-401
BackgroundThe first and most important step in characterizing familial nonmedullary thyroid carcinoma (NMTC) is to distinguish the true familial patients, which is the prerequisite for all accurate analyses. This study aimed to investigate whether patients from families with ≥3 first-degree relatives affected with NMTC have different characteristics than patients from families with only two affected members, and to compare these patients with those with sporadic disease.
Methods:We analyzed the clinicopathological features and prognosis of 209 familial and 1120 sporadic cases of NMTC. Familial patients were further divided into two subgroups: families with two affected members and families with ≥3 affected members.
Results:The familial group had a significantly higher risk of bilateral growth, multifocality, extrathyroidal extension, and lateral lymph node metastasis than the sporadic group (P < 0.05). These main features were also different between the group with ≥3 affected members and the sporadic group. The only difference between the two affected members' group and the sporadic group was incidence of multifocality (P < 0.05). The probability of disease recurrence in patients from families with ≥3 affected members was significantly higher than that in sporadic cases (14.46% vs. 5.27%; P = 0.001), while the probability in patients from families with two affected members was similar to that in sporadic patients (6.35% vs. 5.27%; P = 0.610). The Kaplan-Meier survival analysis showed a statistically significant difference in disease-free survival between the two subgroups (85.54% vs. 93.65%; P = 0.045).
Conclusions:Patients from families with ≥3 members affected by NMTC have more aggressive features and a worse prognosis than those from families with only two affected members. Patients from families with ≥3 affected first-degree relatives may be considered to have true familial NMTC.
6. Clinical application value of combined detection of serum miR-378 and miR-21 in gastric cancer
Shengkai HUANG ; Jia WANG ; Yan LI ; Hong LIN ; Dongdong LI ; Chanjuan CUI ; Guojing WANG ; Xuexiang LI ; Lin YANG ; Mei ZHAO ; Changzhi HUANG
Chinese Journal of Oncology 2018;40(6):441-445
Objective:
To investigate the clinical value of combined detection of serum miR-378 and miR-21 in gastric cancer (GC).
Methods:
Eighty-seven patients with GC and 78 patients with colorectal cancer(CRC) from National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences were selected, 83 individuals undergoing healthy physical examination were selected as the healthy controls. The levels of serum miR-378 and miR-21 were detected by quantitative real-time PCR (RT-qPCR) (result data were transformed as log2 for analysis).
Results:
Relative expression levels of miR-378 in the serum were -1.24, -3.25 and -2.73 in healthy controls, GC and CRC patients, respectively. Compared with the healthy controls, the levels of serum miR-378 were significantly decreased in GC and CRC patients (both
7.Inhibitory effect of stomatin-like protein 2 (SLP-2) on growth of transplanted tumor of esophageal squamous cell carcinoma in nude mice
SONG Shuai ; TIAN Di ; CUI Yong ; GAO Zhi ; WANG Tianyou ; HU Jian ; CHANG Dong
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2018;25(10):885-889
Objective To observe the growth of orthotopic transplanted tumor in nude mice after stomatin-like protein 2 (SLP-2) expression decreased, and to further study the role of SLP-2 in the development and progression of esophageal squamous cell carcinoma. Methods Using RNA interference technique, esophageal squamous cell carcinoma cell lines with specific expression of SLP-2 and stable expression of luciferase were established. The healthy female nude mice with weight ranging from 19 to 22 g were randomly divided into 3 groups (n=12), 6 mice were used to establish subcutaneous xenografts, and the other 6 mice were used to establish the orthotopic transplanted tumor model (Group 1: cell infected with SLP-2-1 plasmid; group 2: cell infected with SLP-2-2 plasmid; group 3: cell infected with SHGFP plasmid). Index of the experiment end was weight loss and poor general situation in any mouse. Before the nude mice were sacrificed, the luciferase value of the tumor was detected by using in vivo imaging technique. After the nude mice were sacrificed, the primary tumor was removed for pathology examination. Results There was no significant difference in region of interest (ROI) value between the group 1 and group 2 (P=0.943). The ROI value for both groups 1 and 2 was significantly lower than that in the group 3 (P=0.002, P=0.000). The primary tumor infiltrated into the muscularis propria of esophageal was observed in all groups. Conclusion SLP-2 is involved in the development and progression of esophageal squamous cell carcinoma, and the decrease of SLP-2 expression can inhibit the growth of esophageal squamous cell carcinoma.
8.Hyperbaric oxygen therapy improves the effect of keloid surgery and radiotherapy by reducing the recurrence rate.
Ke-Xin SONG ; Shu LIU ; Ming-Zi ZHANG ; Wei-Zhong LIANG ; Hao LIU ; Xin-Hang DONG ; You-Bin WANG ; Xiao-Jun WANG
Journal of Zhejiang University. Science. B 2018;19(11):853-862
OBJECTIVE:
Keloids are exuberant cutaneous scars that form due to abnormal growth of fibrous tissue following an injury. The primary aim of this study was to assess the efficacy and mechanism of hyperbaric oxygen therapy (HBOT) to reduce the keloid recurrence rate after surgical excision and radiotherapy.
METHODS:
(1) A total of 240 patients were randomly divided into two groups. Patients in the HBOT group (O group) received HBOT after surgical excision and radiotherapy. Patients in the other group were treated with only surgical excision and radiotherapy (K group). (2) Scar tissue from recurrent patients was collected after a second operation. Hematoxylin and eosin (H&E) staining was used to observe keloid morphology. Certain inflammatory factors (interleukin-6 (IL-6), hypoxia-inducible factor-1α (HIF-1α), tumor necrosis factor-α (TNF-α), nuclear factor κB (NF-κB), and vascular endothelial growth factor (VEGF)) were measured using immunohistochemical staining.
RESULTS:
(1) The recurrence rate of the O group (5.97%) was significantly lower than that of the K group (14.15%), P<0.05. Moreover, patients in the O group reported greater satisfaction than those in the K group (P<0.05). (2) Compared with the recurrent scar tissue of the K group, the expression levels of the inflammatory factors were lower in the recurrent scar tissue of the O group.
CONCLUSIONS
Adjunctive HBOT effectively reduces the keloid recurrence rate after surgical excision and radiotherapy by improving the oxygen level of the tissue and alleviating the inflammatory process.
Adolescent
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Adult
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Female
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Humans
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Hyperbaric Oxygenation
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Hypoxia-Inducible Factor 1, alpha Subunit/blood*
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Inflammation
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Interleukin-6/blood*
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Keloid/surgery*
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Male
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Middle Aged
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NF-kappa B p50 Subunit/blood*
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Perfusion
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Recurrence
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Surveys and Questionnaires
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Tumor Necrosis Factor-alpha/blood*
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Vascular Endothelial Growth Factor A/blood*
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Young Adult
9.Clinical characteristics and OCT findings of focal choroidal excavation in 39 cases
International Eye Science 2017;17(5):912-916
AIM: To observe the clinical features and optical coherence tomography(OCT)characteristics of focal choroidal excavation(FCE).
METHODS: The medical records of patients with FCE determined by OCT during the period of time from January 2014 to January 2016 were reviewed and analyzed. All patients underwent systematic ophthalmic examinations, including visual acuity, refractive status, slit lamp, ophthalmoscopy, OCT, etc.
RESULTS: Totally 24 men(26 eyes)and 15 women(16 eyes)were included in this study(20 left eyes, 16 right eyes, and 3 cases of bilateral eyes). The average age of patients was 50.4±16.7 years old. The range of patients refraction was(-2.51±2.60)D, and best corrected visual acuity(BCVA)was 0.60±0.26. Forty-six lesions were observed in 39 patients(42 eyes), with 37 cases(80%)of the conforming type and 9 cases(20%)of the nonconforming type. The average lesion width was 648.4±249.2μm and average depth was 128.0±50.4μm. BCVA in patients with the lesion under the fovea(16, 35%)was significantly lower than that with the lesion outside the fovea(P<0.05). FCE was complicated with choroidal neovascularization(CNV)in 3 cases, macular epiretinal membranes(ERM)in one case, macular hole and(epiretinal membrane)ERM in one case, macular lamellar hole and ERM in one case. There was no significant correlation among patient's age, visual acuity, FCE width and FCE depth in linear correlation analysis(P>0.05).
CONCLUSION: FCE were mainly found in aging patients with mild and moderate myopia, mostly belonged to the conforming type in single eye. FCE was observed to complicate with macular hole, macular ERM and CNV. The visual acuity may be affected with FCE under the fovea. Further study on its etiology of FCE is needed.
10.Tracheal glomus tumor: two cases with bronchoscopic intervention.
Wei XIONG ; Cunliang CAI ; Yunzhi ZHOU ; Nan ZHANG ; Hongwu WANG
Chinese Medical Journal 2014;127(1):189-190
Bronchoscopy
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methods
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Female
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Glomus Tumor
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surgery
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Humans
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Male
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Middle Aged
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Tracheal Neoplasms
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surgery


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